Job Description
Summary: OF POSITION RESPONSIBILITIES
Analytical Sciences Strategy and Execution
- Develop CMC Department’s analytical strategy in alignment with company objectives and drive execution of such strategy.
- Set specifications and provide technical oversight of all analytical testing to advance R&D clinical projects and deliver commercial supplies.
- Direct analytical method development, validation, and transfer for small molecule and peptide drug substances, raw materials, and drug products.
- Manage product and analytical lifecycle changes and drive improvements for drug substance, raw materials, and drug product.
- Direct external consultants, contract labs, contract supplier technical teams, and other external technical resources.
- Design and execute appropriate drug substance and drug product stability programs to support product development, registration, and commercial supply.
- Prepare supporting documentation for technical projects including risk assessments, data analysis, and technical reports, as required.
Data Quality and Regulatory Analysis
- Review analytical release and stability data and perform data analysis and trending in support of projects.
- Prepare analytical sections of regulatory submissions including IND, IMPDs, milestone briefing packages (Pre IND/NDA Meetings, EOP2 Agency Meetings), NDA, SNDA, MAA and other global regulatory submissions.
- Work with Quality and Technical Operations teams and provide SME input to ensure all Out-of-Specification and Laboratory Investigation issues are investigated and resolved in a timely manner.
- Interact with international regulatory agencies on CMC analytical topics, as appropriate.
- Contribute to authoring and maintenance of SOPs appropriate for cGMP compliance.
Maintain Operational Excellence
- Act as Subject Matter Expert across the company to support decisions, solve problems, and drive improvements in clinical, non-clinical, regulatory, operations, and product development functions.
- Develop and maintain strong relationships with key stakeholders and external SMEs, as needed.
- Monitor and drive vendor performance.
EDUCATION AND EXPERIENCE REQUIREMENTS
- PhD degree in Analytical Chemistry or related field. At least 15+ years of progressively responsible experience in Analytical Sciences within the pharmaceutical and/or medical device industries, combination products, peptides, small molecules, CMC, drug substance and drug product, clinical and non-clinical.
- Must have knowledge of the relevant regulations, regulatory process, and requirements
- Extensive experience in Drug Product analysis including Raw Materials, Specifications, method development, method validation, and method transfer
- Must have demonstrated experience in managing teams of diverse analytical backgrounds including analytical work at CRO/CDMOs
- Strong written and oral communication skills
- Commitment to Verrica’s vision, mission, core values and culture.
PHYSICAL POSITION REQUIREMENTS
Must be able to sit for extended periods of time at a desk. Normal requirements for office operations with respect to lifting, standing and walking.
JOIN US!
For the opportunity to be part of a ground-floor commercial team at a growing pharmaceutical company
- Autonomy, trust, and the ability to help shape access strategy—not just execute it
- A fast-moving culture where your voice matters and your work has real impact
- Competitive compensation, equity, and benefits
- Performance-based discretionary bonus compensation
- This position includes medical, dental, vision insurance as well as a 401k plan and paid time off
If you’re passionate about helping patients access medicines, energized by challenge, and excited by the opportunity to help shape the future of dermatology — let’s talk!
Job Tags
Full time, Contract work, Work at office